The following is a review of diagnostic product developments worldwideThe information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.
The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.
Product developments in September 2003
Accumetrics Incorporated has signed an exclusive agreement with Fisher HealthCare, a division of Fisher Scientific Company LLC that provides Fisher with the exclusive right to distribute Accumetrics products into the US hospital market. Accumetrics recently received FDA clearance to market the Ultegra Rapid Platelet Function Assay-Aspirin (RPFA-ASA) product.
Akers Biosciences Inc. has formed an alliance with FirstRx, Inc. to market and distribute Akers rapid diagnostic tests to US healthcare markets. FirstRx will market Akers' tests for sexually transmitted diseases, drugs of abuse, rheumatoid arthritis, cholesterol, and PSA. Most of these products will be introduced in the fourth quarter of 2003; the PSA test will be introduced once regulatory approval is obtained.
Baxter International Inc. and Cerus Corp. have halted clinical trials of the Intercept Blood System after two patients developed antibodies to red blood cells treated with the compound. The companies said they plan to evaluate the available clinical data to determine the appropriate course of action for their investigational pathogen inactivation system for red blood cells.
Bio-Rad Laboratories, Inc. has received FDA clearance to market its D-10 Hemoglobin A1c system which includes both the D-10 instrument and Hemoglobin A1c test kit.
DakoCytomation has received exclusive worldwide rights to two antibodies for prostate cancer diagnostics and monitoring from Corixa Corporation. The marker P504S is a tumor specific marker and P501S is specific for prostate tissue.
Genelabs Diagnostics Pte Ltd has developed a rapid SARS test with the Singapore government-run Institute of Molecular and Cell Biology.
Haemonetics Corporation has received FDA clearance to market its cell wash protocol on the Haemonetics ACP 215 platform. The protocol removes more than 99% of plasma proteins from red blood cells.
Hycor Biomedical Inc. and Beckman Coulter Inc. have signed a multi-year, exclusive, worldwide agreement by which Hycor will develop and supply a broad menu of automated tests for certain autoimmune disease markers on Beckman Coulter's Access Immunoassay platforms including the UniCel DxI 800 and the SYCHRON LX i 725. The tests use Beckman Coulter's magnetic particle chemiluminescence technology and Hycor's library of antigens and antibodies.
InPro Biotechnology, Inc. has acquired a license to a rapid and highly sensitive test for mad-cow disease in living animals, developed at the University of California-San Francisco. InPro reports that a tissue or blood test for BSE in live cattle could be available in a year. It may eventually be used to screen people for the human form of mad-cow disease.
Inverness Medical Innovations, Inc. has acquired certain assets from Abbott Laboratories' rapid diagnostics business. Inverness has acquired assets related to the Fact plus pregnancy test and the Abbott TestPack, Abbott TestPack plus and Signify lines of rapid diagnostics outside the US.
i-STAT Corporation has received FDA clearance to market 2 assays - the i-STAT System Cardiac Troponin I (cTnI) test and the kaolin-based activated clotting time (kaolinACT) test.
Nanogen, Inc. and Prodesse, Inc. are collaborating to develop automated microarray- based products to detect infectious disease agents, including influenza, pneumonia, adenovirus, herpes, West Nile Virus, and SARS. The Companies will integrate Prodesse's proprietary multiplex amplification technology with the NanoChip platform.
OraSure Technologies, Inc. has received FDA clearance to market its OraQuick Rapid HIV-1 Antibody Test for use in detecting HIV-1 antibodies in venipuncture whole blood specimens. In November 2002, the company received approval for use of the OraQuick test with fingerstick whole blood specimens.
Thermo Electron Corporation has received FDA clearance to market its BioStar rapid differentiated influenza test, FLU OIA A/B, which can distinguish between influenza A and influenza B.
Product developments - Summer 2003
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Last modified: October 2, 2003